risk assessment process
IRI: https://spec.industrialontologies.org/ontology/construct/RiskAssessmentProcess
Defined In: https://spec.industrialontologies.org/ontology/biopharma/BiopharmaRiskManagement/
SubClass Of: planned process
Class Hierarchy
owl:Thing › bfo:entity › bfo:occurrent › bfo:process › planned process › risk assessment process
Definition
planned process that consists of the identification of hazards and the analysis and evaluation of the risks associated with those hazards
Semi-Formal Definition:
every instance of ‘risk assessment process’ is defined as exactly an instance of ‘planned process’ that ‘has occurrent part’ some ‘hazard identification process’ producing a ‘hazard specification’, ‘has occurrent part’ some subsequent ‘risk analysis process’ that uses that hazard specification and produces a ‘risk estimate’, ‘has occurrent part’ some subsequent ‘risk evaluation process’ that uses that same risk estimate, and ‘has specified output’ some ‘risk assessment result’ containing that same ‘risk estimate’
Explanatory Notes
A risk-assessment process systematically determines the likelihood and impact of undesirable events or conditions to support informed decision-making. It establishes a basis for prioritising control measures, mitigation strategies, or further study. In pharmaceutical development, it underpins Quality by Design (QbD) activities by identifying process parameters, material attributes, or operational factors that may affect critical quality attributes (CQAs) or key performance indicators (KPIs).
Examples
- During process development, a team conducts a risk assessment process for the objective of meeting a target impurity profile. The team identifies candidate hazards and risk relevant factors such as temperature excursions, pH control drift, and raw material variability, analyzes each risk using an agreed method and scoring rubric, and evaluates the results against predefined criteria to produce a ranked list of factors to investigate in the next DoE study; Before tech transfer, a team conducts a risk assessment process focused on maintaining sterility assurance and product potency. The team identifies failure scenarios across unit operations, analyzes likelihood and impact using platform knowledge and available data, and evaluates which scenarios require additional controls, monitoring, or procedural changes before routine manufacturing.
Adapted From
- https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich-guideline-q9-r1-quality-risk-management-step-5-revision-2_en.pdf and ISO 31000:2018
Formal Axioms
First-Order Logic Definition
RiskAssessmentProcess(x) ↔ PlannedProcess(x) ∧ ∃h∃a∃e∃s∃r∃o(HazardIdentificationProcess(h) ∧ RiskAnalysisProcess(a) ∧ RiskEvaluationProcess(e) ∧ HazardSpecification(s) ∧ RiskEstimate(r) ∧ RiskAssessmentResult(o) ∧ hasOccurrentPart(x,h) ∧ hasOccurrentPart(x,a) ∧ hasOccurrentPart(x,e) ∧ hasSpecifiedOutput(h,s) ∧ hasInput(a,s) ∧ hasSpecifiedOutput(a,r) ∧ hasInput(e,r) ∧ precededBy(a,h) ∧ precededBy(e,a) ∧ hasSpecifiedOutput(x,o) ∧ hasContinuantPartAtAllTimes(o,r))
Description Logic
constr:RiskAssessmentProcess ≡ constr:PlannedProcess ⊓ ∃ bfo:has_occurrent_part .constr:HazardIdentificationProcess ⊓ ∃ bfo:has_occurrent_part .constr:RiskAnalysisProcess ⊓ ∃ bfo:has_occurrent_part .constr:RiskEvaluationProcess ⊓ ∃ constr:hasSpecifiedOutput .constr:RiskAssessmentResult
EquivalentTo: constr:PlannedProcess and bfo:has_occurrent_part some constr:HazardIdentificationProcess and bfo:has_occurrent_part some constr:RiskAnalysisProcess and bfo:has_occurrent_part some constr:RiskEvaluationProcess and constr:hasSpecifiedOutput some constr:RiskAssessmentResult
SubClassOf: constr:PlannedProcess